To Study the Characteristics of Different Types of Vertigo in Patients Attending the Ear Nose & Throat (ENT) Clinics. (VERTIGO)

May 27, 2015 updated by: Abbott

To Study the Characteristics of Different Types of Vertigo in Patients Attending the ENT Clinics.

The VERTIGO study is likely to help determine characteristics of different types of vertigo in patients presenting in the Ear Nose & Throat (ENT) clinics with complaints of dizziness. Moreover, it will also help to develop an understanding about the current management practices of this condition at local level.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Hyderabad, Pakistan, 76090
        • Research facility ID ORG-001139
      • Islamabad, Pakistan, 44000
        • Research facility ID ORG-001053
      • Karachi, Pakistan, 75050
        • Research facility ID ORG-001070
      • Karachi, Pakistan, 75190
        • Research facility ID ORG-001051
      • Karachi, Pakistan, 75900
        • Research facility ID ORG-001069
      • Karachi, Pakistan, 75950
        • Research facility ID ORG-001050
      • Lahore, Pakistan, 54570
        • Research facility ID ORG-001060
      • Lahore, Pakistan, 54660
        • Research facility ID ORG-001054
      • Lahore, Pakistan, 54660
        • Research facility ID ORG-001055
      • Lahore, Pakistan, 54810
        • Research facility ID ORG-001061
      • Peshawar, Pakistan, 7041298
        • Research facility ID ORG-001052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic/Private Clinic

Description

Inclusion Criteria:

  • Male or female patients 18 years of age and older
  • Patients with vestibular vertigo of known or unknown origin
  • Patients who are willing and able to provide written informed consent

Exclusion Criteria:

  • Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion based on clinical judgment
  • Patient with psychiatric disorders, significant neurological disorder or spinal cord damage that would make the evaluation difficult for the investigator
  • Patients who are not willing to give informed consent
  • Patients with a known history of hypersensitivity to betahistine
  • Patients with a history of pheochromocytoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Dizziness
Patients with Dizziness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics (Different Types) of dizziness
Time Frame: 6 months
It will be determined that a patient with dizziness is suffering from what type of Vertigo i.e. Benign Paroxysmal Positional Vertigo, Menier's Disease, Vestibular Neuritis, Labyrinthitis or any other. As these are clinical types of Vertigo these cannot be measured in units
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL) of patients at baselines
Time Frame: 6 months
Dizziness Handicap Inventory will be used
6 months
Management of vertigo currently in practice
Time Frame: 6 months
As per practice of the physician/Investigator. Management of Vertigo is either by certain maneuvers such as Epley's and Simont or by medications. For the maneuvers, no unit can be defined. The information for medication which will be collected will be Name (preferably the generic name), Dose, Units (form of the medicine), Route and Frequency.
6 months
QoL of patients post treatment
Time Frame: 6 months
Dizziness Handicap Inventory will be used
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Dimension Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BETA5003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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